LEVOTHYROXINE SODIUM | N021292 | EMD SERONO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Goodwin Procter LLP (on behalf of Amneal Pharmaceutical... FDA-2018-P-4832 Amneal Pharmaceuticals LLC, represented by Goodwin Procter LLP, filed this citizen petition on December 21, 2018, requesting that the FDA change the therapeutic equivalence ratings in the Orange Book from "AB2" to "BX" for all strengths of Euthyrox (levothyroxine sodium) tablets under NDA 021292, an | 505(q) | 2018-12-21 | Denied | Goodwin Procter LLP (on behalf of Amneal Pharmaceuticals LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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